Tapiwa G Mbengeranwa, Lauren Ziemba, Sean S Brummel, Ben Johnston, Haseena Cassim, Gerhard Theron, Zukiswa Ngqawana, Deo Wabwire, Katie McCarthy, John Shepherd, Shahin Lockman, Lameck Chinula, Lynda Stranix-Chibanda
{"title":"围生期暴露于母体多替替韦与依非韦伦、富马酸替诺福韦与替诺福韦α胺的婴儿的骨矿物质含量、生长和肾脏健康：随机IMPAACT 2010 （VESTED）试验","authors":"Tapiwa G Mbengeranwa, Lauren Ziemba, Sean S Brummel, Ben Johnston, Haseena Cassim, Gerhard Theron, Zukiswa Ngqawana, Deo Wabwire, Katie McCarthy, John Shepherd, Shahin Lockman, Lameck Chinula, Lynda Stranix-Chibanda","doi":"10.1097/QAI.0000000000003656","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The impact on infant bone, growth, and renal health of in utero and breast milk exposure to contemporary antiretroviral treatment (ART) remains unclear.</p><p><strong>Methods: </strong>Six hundred forty-three pregnant women with HIV in 9 countries in Africa, Asia, and the Americas were randomized to start ART with dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide (TAF), DTG + FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF between 14 and 28 weeks' gestation and continued for 50 weeks postpartum. Pairwise comparisons used 2-sample t tests of mean week 26 infant bone mineral content (BMC) assessed by dual-energy X-ray absorptiometry in a subset; mean infant z-scores for length-for-age z-score (LAZ), weight-for-age z-score (WAZ), and weight-for-length (WLZ) at 26 and 50 weeks; and mean infant creatinine and estimated creatinine clearance at birth and 26 weeks.</p><p><strong>Results: </strong>Five hundred seventy-seven infants were included in the growth analysis, and 169 in the dual-energy X-ray absorptiometry analysis. Week 26 infant spine BMC was significantly lower in the EFV/FTC/TDF arm (133.5 g) than in the DTG + FTC/tenofovir alafenamide [143.4 g; mean difference (95% confidence intervals): 0.22 (0.02, 0.42) g] and DTG + FTC/TDF [137.4; mean difference (95% confidence interval): 0.20 (0.01, 0.40) g] arms. Mean LAZ and WAZ scores through week 50 were also significantly lower in the EFV/FTC/TDF versus DTG arms, but not WLZ. Infant obesity was rare (2%-4%) and similar between arms. There was no apparent by-arm difference in infant creatinine or estimated creatinine clearance through week 50 ( P -values ≥ 0.18).</p><p><strong>Conclusions: </strong>It is reassuring that maternal DTG-based ART during pregnancy and breastfeeding was associated with higher infant spine BMC, better growth, and less stunting than EFV/FTC/TDF.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"211-219"},"PeriodicalIF":2.2000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455726/pdf/","citationCount":"0","resultStr":"{\"title\":\"Bone Mineral Content, Growth, and Renal Health of Infants With Perinatal Exposure to Maternal Dolutegravir Versus Efavirenz and Tenofovir Disoproxil Fumarate Versus Tenofovir Alafenamide: The Randomized IMPAACT 2010 (VESTED) Trial.\",\"authors\":\"Tapiwa G Mbengeranwa, Lauren Ziemba, Sean S Brummel, Ben Johnston, Haseena Cassim, Gerhard Theron, Zukiswa Ngqawana, Deo Wabwire, Katie McCarthy, John Shepherd, Shahin Lockman, Lameck Chinula, Lynda Stranix-Chibanda\",\"doi\":\"10.1097/QAI.0000000000003656\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The impact on infant bone, growth, and renal health of in utero and breast milk exposure to contemporary antiretroviral treatment (ART) remains unclear.</p><p><strong>Methods: </strong>Six hundred forty-three pregnant women with HIV in 9 countries in Africa, Asia, and the Americas were randomized to start ART with dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide (TAF), DTG + FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF between 14 and 28 weeks' gestation and continued for 50 weeks postpartum. Pairwise comparisons used 2-sample t tests of mean week 26 infant bone mineral content (BMC) assessed by dual-energy X-ray absorptiometry in a subset; mean infant z-scores for length-for-age z-score (LAZ), weight-for-age z-score (WAZ), and weight-for-length (WLZ) at 26 and 50 weeks; and mean infant creatinine and estimated creatinine clearance at birth and 26 weeks.</p><p><strong>Results: </strong>Five hundred seventy-seven infants were included in the growth analysis, and 169 in the dual-energy X-ray absorptiometry analysis. Week 26 infant spine BMC was significantly lower in the EFV/FTC/TDF arm (133.5 g) than in the DTG + FTC/tenofovir alafenamide [143.4 g; mean difference (95% confidence intervals): 0.22 (0.02, 0.42) g] and DTG + FTC/TDF [137.4; mean difference (95% confidence interval): 0.20 (0.01, 0.40) g] arms. Mean LAZ and WAZ scores through week 50 were also significantly lower in the EFV/FTC/TDF versus DTG arms, but not WLZ. Infant obesity was rare (2%-4%) and similar between arms. There was no apparent by-arm difference in infant creatinine or estimated creatinine clearance through week 50 ( P -values ≥ 0.18).</p><p><strong>Conclusions: </strong>It is reassuring that maternal DTG-based ART during pregnancy and breastfeeding was associated with higher infant spine BMC, better growth, and less stunting than EFV/FTC/TDF.</p>\",\"PeriodicalId\":14588,\"journal\":{\"name\":\"JAIDS Journal of Acquired Immune Deficiency Syndromes\",\"volume\":\" \",\"pages\":\"211-219\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455726/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAIDS Journal of Acquired Immune Deficiency Syndromes\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/QAI.0000000000003656\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAIDS Journal of Acquired Immune Deficiency Syndromes","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/QAI.0000000000003656","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Bone Mineral Content, Growth, and Renal Health of Infants With Perinatal Exposure to Maternal Dolutegravir Versus Efavirenz and Tenofovir Disoproxil Fumarate Versus Tenofovir Alafenamide: The Randomized IMPAACT 2010 (VESTED) Trial.
Background: The impact on infant bone, growth, and renal health of in utero and breast milk exposure to contemporary antiretroviral treatment (ART) remains unclear.
Methods: Six hundred forty-three pregnant women with HIV in 9 countries in Africa, Asia, and the Americas were randomized to start ART with dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide (TAF), DTG + FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF between 14 and 28 weeks' gestation and continued for 50 weeks postpartum. Pairwise comparisons used 2-sample t tests of mean week 26 infant bone mineral content (BMC) assessed by dual-energy X-ray absorptiometry in a subset; mean infant z-scores for length-for-age z-score (LAZ), weight-for-age z-score (WAZ), and weight-for-length (WLZ) at 26 and 50 weeks; and mean infant creatinine and estimated creatinine clearance at birth and 26 weeks.
Results: Five hundred seventy-seven infants were included in the growth analysis, and 169 in the dual-energy X-ray absorptiometry analysis. Week 26 infant spine BMC was significantly lower in the EFV/FTC/TDF arm (133.5 g) than in the DTG + FTC/tenofovir alafenamide [143.4 g; mean difference (95% confidence intervals): 0.22 (0.02, 0.42) g] and DTG + FTC/TDF [137.4; mean difference (95% confidence interval): 0.20 (0.01, 0.40) g] arms. Mean LAZ and WAZ scores through week 50 were also significantly lower in the EFV/FTC/TDF versus DTG arms, but not WLZ. Infant obesity was rare (2%-4%) and similar between arms. There was no apparent by-arm difference in infant creatinine or estimated creatinine clearance through week 50 ( P -values ≥ 0.18).
Conclusions: It is reassuring that maternal DTG-based ART during pregnancy and breastfeeding was associated with higher infant spine BMC, better growth, and less stunting than EFV/FTC/TDF.
期刊介绍：
JAIDS: Journal of Acquired Immune Deficiency Syndromes seeks to end the HIV epidemic by presenting important new science across all disciplines that advance our understanding of the biology, treatment and prevention of HIV infection worldwide.
JAIDS: Journal of Acquired Immune Deficiency Syndromes is the trusted, interdisciplinary resource for HIV- and AIDS-related information with a strong focus on basic and translational science, clinical science, and epidemiology and prevention. Co-edited by the foremost leaders in clinical virology, molecular biology, and epidemiology, JAIDS publishes vital information on the advances in diagnosis and treatment of HIV infections, as well as the latest research in the development of therapeutics and vaccine approaches. This ground-breaking journal brings together rigorously peer-reviewed articles, reviews of current research, results of clinical trials, and epidemiologic reports from around the world.
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